Effect of Epigallocatechin-3-Gallate Solution as a Root Canal Irrigant on Post-Operative Pain Intensity and Bacterial Load Reduction in Necrotic Tooth

Not Applicable

Completed

• Conditions: Necrotic Pulp
• Interventions: Other: sodium hypochlorite; Other: Epigallocatechin-3-gallate

• Registration Number: NCT05988788
• Lead Sponsor: Cairo University

Brief Summary

clinically compare the intensity of post-operative pain and the amount of bacterial load reduction after using 20% Epigallocatechin-3-gallate solution during chemomechanical preparation, versus 2.5% NaOCl, in asymptomatic necrotic mandibular premolars treated in a single visit.

Detailed Description

The patients will be randomly divided into 2 groups. Intervention group (20% epigallocatechin-3-gallate solution root canal irrigant) and control group (2.5% sodium hypochlorite root canal irrigant).

Post-operative pain will be measured at 6, 12, 24 and 48 hours post-operatively. The pain will be recorded using the Numerical Rating Scale (NRS).

Amount of bacterial load reduction The intracanal bacterial load reduction will be determined using agar culture technique by counting the colony forming units per milliliter (CFUs/mL) before and after root canal preparation.

Study Timeline

• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-08-09
• Study First Posted: 2023-08-14
• Study Start: 2023-10-01
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sodium hypochlorite	sodium hypochlorite	2.5% sodium hypochlorite
Epigallocatechin-3-Gallate	Epigallocatechin-3-gallate	20% Epigallocatechin-3-Gallate solution

Primary Outcome Measures

Name	Time	Method
Postoperative pain	Postoperative pain measured at 6, 12, 24, 48 hours after single visit treatment.	Categorical None 0 Mild 1-3 Moderate 4-6 Severe 7-10

Secondary Outcome Measures

Name	Time	Method
Amount of intracanal bacterial load reduction	T0: preintervention, preinstrumentation after access cavity. T1: postinstrumentation up to 10 min	The intracanal bacterial load reduction will be determined using agar culture technique by counting the colony forming units per milliliter (CFUs/mL) before and after root canal preparation

Trial Locations

Locations (1)

Dentistry; 🇪🇬 Cairo, Egypt